While in Italy there is stability in the new HIV diagnoseswith a worrying increase in late cases as demonstrated by the data released on the occasion of World AIDS Day, attention is growing on a new frontier in prevention. It’s about the PrEP long-actinga periodic injection that tries to make the issue of adherence less problematic, which can instead occur in oral therapy. A revolution that sees Italy at the forefront, with pilot projects already in place and first-rate studies on the topic at European level. The scope of the latest research progress is explained to ilfattoquotidiano.it Andrea GoriDirector of the Department of Infectious Diseases at theSacco Hospital of Milan and President of the Lombard section of Anlaids.
After oral PrEP, long-acting injectable PrEP is an additional weapon to fight the HIV virus. What is it specifically about?
Rather than injectable PrEP, we need to talk about long-acting PrEP, which exploits the characteristics of long-acting drugs, i.e. slow-release drugs available by injection. Two of those, in the future, in our possession: the first, Cabotegravir, is now under negotiation in AIFA regarding reimbursement, the second, Lenacapavir, has just been approved at FDA level (Food and Drug Administration, ed.) and is under negotiation at the EMA (European Medicines Agency, ed.). At the moment Cabotegravir is administered every two months, while Lenacapavir every 6. However, some trials will soon start for the administration of Cabotegravir every 4 months, and Lenacapavir once a year.
How does Italy position itself in relation to these scenarios?
The only European data that there is today on Cabotegravir long-acting PrEP comes from Italian studies carried out in collaboration between the Sacco and Spallanzani hospitals in Rome. In these studies recently presented at the EACS European congress, the effectiveness of the drug in low-adherence subjects who have problems carrying out oral PrEP therapy was demonstrated.
That is to say?
PrEP is 100% effective if it is taken correctly, but oral PrEP – which can be taken every day or on demand – presents some problems in terms of adherence. Another study, again in collaboration between Spallanzani and Sacco, has in fact highlighted that after about a year and a half of observation, 50% of people on oral PrEP continue to follow the therapy correctly, the other 50% do not. This second group therefore inadvertently exposes itself to a significant risk of infection. In fact, he thinks he is still protected by prophylaxis when on the contrary he is not, as he takes it incorrectly. A problem that is eliminated with long-acting PrEP. By giving an injection every two, four or six months – and it will reach just once a year – you can significantly reduce adherence problems. The revolution lies precisely in this.
Are there any other advantages?
After the injection, the patient no longer has to think about the therapy for two months, thus reducing the stress linked to the fear of infection and the stigma that can derive from having to take a drug every day. Long-acting PrEP is an extremely effective alternative even when dealing with people who are difficult to reach in hospital, such as sex workers, or individuals with psychological or psychiatric problems who struggle to adhere to oral therapy.
Are there any cons instead?
Long-acting PrEP is not cheap at all. The costs are high and it is therefore unsustainable to think of administering it to everyone without distinction. At the moment, it is therefore proposed to offer it to those who are unable to adhere to oral therapy or have problems taking it.
Does anything change regarding mandatory checks related to PrEP?
The protocol is exactly identical. When you receive the injection – for now every two months – checks related to sexually transmitted infections are also carried out.
Are these pilot projects encountering any bureaucratic problems?
No, the ethics committees have approved the study and the observation is continuing.
Now what will happen?
ViiV (a pharmaceutical company 100% dedicated to research into treatments against HIV, ed.) is defining the negotiation phase with AIFA, in which the price and methods of distribution of the drug are established. This means that the access criteria will have to be decided, based on what AIFA establishes.
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